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Primary Care, Communication, and Improving Children's Health

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ClinicalTrials.gov Identifier: NCT02277899
Recruitment Status : Completed
First Posted : October 29, 2014
Last Update Posted : May 19, 2020
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center

Brief Summary:
The purpose of this study is to determine communication content and strategies in primary care that predict improvement in weight status among overweight school-age children.

Condition or disease Intervention/treatment
Childhood Obesity Overweight Communication Weight Loss Other: Communication regarding overweight status Other: Risk-factor assessment and counseling Other: Lifestyle behavior assessment and counseling Other: Interval follow-up to readdress weight Other: Patient-centered communication

Detailed Description:
We will test whether 1) pediatrician-patient communication regarding overweight status, behavior/risk-factor counseling, and the frequency and time to next follow-up visit, compared with either no communication or incomplete communication (communicating only high weight status without behavior/risk-factor counseling or a follow-up visit) will predict improvement in weight status at one year follow-up, and 2) during pediatrician-patient communication regarding weight and weight management, higher patient-centeredness will predict improvement in weight status at one year follow-up. The communication content identified will generate new information about the most effective content and style of pediatrician-patient communication that predict weight-status improvement. Because we prospectively will examine clinical practice elements in the one-year interval between well-child visits, acknowledging that communication regarding high weight status may initiate assessment of risk factors for heart disease (such as high cholesterol and blood sugar), more frequent follow-up visits, or prompt a nutrition referral, we will generate novel information about the most effective clinical practices and follow-up interval and frequency that predict weight-status improvement in overweight children. We also will examine if the content and style of communication are related to improvements in diet and lifestyle behaviors at one-year follow-up.

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Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Primary Care, Communication, and Improving Children's Health
Actual Study Start Date : October 14, 2014
Actual Primary Completion Date : August 5, 2016
Actual Study Completion Date : August 10, 2017

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Overweight school-age children

Overweight 6-12 year-old children. Weight status will be measured and parents complete surveys at baseline and one year later. Pediatricians will complete surveys at baseline, and after index visit. Visits will be directly video-recorded.

The impact of pediatrician clinical practices and communication strategies on child's weight status will be evaluated at one year. Clinical practices (such as risk-factor screening) that occur during the 1-year interval between well-child visits also will be assessed. Specific clinical practice elements and communication strategies that will be examined include:

  1. Communication regarding child's high weight status
  2. Counseling regarding cardiovascular risk factor screening and assessment
  3. Behavioral counseling
  4. Interval follow-up to readdress weight, and
  5. Patient-centeredness, scored as the ratio of patient to doctor-centered communication regarding weight topics.
Other: Communication regarding overweight status
Pediatrician-patient/parent communication regarding child's high weight status

Other: Risk-factor assessment and counseling
Counseling regarding cardiovascular risk factor assessments/results.

Other: Lifestyle behavior assessment and counseling
Counseling regarding diet and lifestyle changes to improve weight status.

Other: Interval follow-up to readdress weight
Interval follow-up to readdress weight, prior to the next well-child visit one year later. Follow-up could include ongoing care through nutrition and/or an intensive weight-management program.

Other: Patient-centered communication
Patient-centered communication will be scored as the ratio of patient to doctor-centered communication regarding weight topics. Means will be calculated for total and weight-communication-specific pediatrician, child, and parent-talk time, and patient, doctor, and the ratio of patient/doctor-centered communication scores. For the primary hypothesis, biomedical information-giving (for example, risk-factor communication) will be treated as patient-centered because the principal investigator's focus groups suggest that parents want this information, and prior research suggests that including biomedical-information giving improves the correlation of Roter's patient-centeredness measure with patient health status and satisfaction scores.




Primary Outcome Measures :
  1. Percent overweight [ Time Frame: From recorded well-child visit to next well-child visit, approximately 12 months later ]
    The percent over the median BMI percentile for age and gender. This measure changes comparably for similar weight changes in overweight and severely-obese children. In contrast, an overweight child would have to lose substantially less weight than a severely-obese child for the same change in BMI z-score.


Secondary Outcome Measures :
  1. BMI z-score [ Time Frame: From recorded well-child visit to next well-child visit, approximately 12 months later ]
    Change in BMI z-score of 0.25-0.5 has been associated with reductions in cardiovascular-disease risk factors. Using both percent overweight and BMI z-score measures will allow examination of the relationship between relative weight changes and cardiovascular-disease risk-factor improvement.


Other Outcome Measures:
  1. Change in the number of "5-2-1-0" behaviors [ Time Frame: From recorded well-child visit to next well-child visit, approximately 12 months later ]
    The "5-2-1-0" behaviors are: eat five fruits and vegetables, watch "screens" (TV, computer, tablets, video games, cell phones, etc…) two hours per day or less, be physically active for one hour per day or more, and drink zero calorie-containing beverages per day.



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
We will recruit pediatricians (from academic, community, and private practices), children, and a consenting parent. Pediatricians and children will be selected to reflect the proportions of minority pediatricians and children in the practices. Pediatricians at the community and private practices will be eligible to participate if they provide outpatient pediatric care ≥20 hours/week. At the academic clinic, only second and third-year residents will be eligible. Eighty-five children and a consenting parent will be recruited.
Criteria

Inclusion Criteria:

  • Schedule a well-child visit with a participating pediatrician
  • Agree to return in one year for the follow-up well-child visit
  • Overweight
  • 6-12 years old
  • Have a working telephone and/or e-mail address
  • Child/parent willing to provide assent/consent

Exclusion Criteria:

  • Unstable illness (such as uncontrolled asthma)
  • Developmental condition (such as trisomy 21)
  • Planning to move/leave practice within two years

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02277899


Locations
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United States, Texas
University of Texas Southwestern and Children's Medical Center
Dallas, Texas, United States, 75390
Sponsors and Collaborators
University of Texas Southwestern Medical Center
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Christy B Turer, MD, MHS University of Texas Southwestern and Children's Medical Center Dallas
Publications:
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Responsible Party: University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT02277899    
Other Study ID Numbers: 1K23HL118152-01A1 Aim 2
1K23HL118152-01A1 ( U.S. NIH Grant/Contract )
First Posted: October 29, 2014    Key Record Dates
Last Update Posted: May 19, 2020
Last Verified: May 2020
Keywords provided by University of Texas Southwestern Medical Center:
childhood obesity
overweight
communication
primary care
weight management
communication methods
patient-centered communication
Additional relevant MeSH terms:
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Pediatric Obesity
Overweight
Weight Loss
Obesity
Overnutrition
Nutrition Disorders
Body Weight
Body Weight Changes